1. Field of the Invention
The present invention relates to aqueous anti-calculus oral compositions comprising certain aluminum-carboxylic acid complexes, and to methods for their use. More particularly, this invention relates to aqueous oral compositions comprising complexes of water-soluble, non-toxic aluminum salts and certain aliphatic carboxylic acids and water-soluble salts thereof.
2. Description of Prior Art
Dental research has developed substantial evidence that beyond the age of 40 years loss of teeth is predominantly the result of periodontal involvements rather than dental caries. An important factor contributing to periodontal disease is the accumulation of dental calculus (e.g., salivary tartar) on the teeth. These deposits contribute to tissue inflammation of the surrounding gingiva, and, as the condition increases in severity, the supporting bone is also affected. These reactions lead to the destruction of the supporting structures and subsequent loss of teeth.
A wide variety of chemical and biological agents have been described in the art for retarding calculus formation or for removing calculus after it is formed. Periodic mechanical removal of calcified deposits by the dentist or dental hygienist is routine dental office procedure. However, a substantial part of the population fail to obtain periodic mechanical removal of deposits, either because of the inconvenience associated with visiting a dentist or for other reasons. Thus, the subject invention has as a primary aspect the utilization of compositions comprising aluminum carboxylate complexes which exhibit surprising and unexpected effectiveness as anti-calculus agents (i.e., agents useful in reducing a tendency of oral hard tissues to accumulate dental calculus), and yet which may be safely employed in the oral cavity.
It has heretofore been suggested by Ritchey, U.S. Pat. No. 4,146,605, that certain aluminum compounds may be effective in anti-calculus compositions adapted for oral use, such as dentifrice preparations, toothpastes and chewing gum. According to the teaching of Ritchey, the aluminum should be "substantially in the ionic form." The Ritchey reference teaches that "the active constituent related to anti-calculus activity is the aluminum ion" and that "a theory explaining the action of aluminum in the present invention is that aluminum may be involved in an exchange type of reaction taken place at the surface of calculus." Compositions in accordance with Ritchey have not been effective against dental calculus, however, apparently because of their reliance on ionic aluminum as the active moiety.
The use of carboxylic acids in combination with calcined kaolin in a chewing gum has also been found to yield anti-calculus benefits. For example, in Muhler, U.S. Pat. No. 4,400,372, such a composition is described as being useful in polishing the teeth so as to remove dental calculus and prevent its reformation. The anti-calculus mechanism of the reference compound is representative of other agents that rely upon physical rather than chemical means to prevent calculus.
The present invention is predicated upon the discovery that complexes of certain aluminum salts and certain aliphatic carboxylic acids and their salts exhibit surprising anti-calculus activity, particularly in comparison to corresponding compositions having either no aluminum or uncomplexed ionic aluminum not in the presence of a complexing aliphatic carboxylic acid or a salt thereof.
Accordingly, it is a primary object of this invention to provide new and unique oral compositions characterized by the inclusion of an aluminum-carboxylate complex comprising a non-toxic aluminum salt and a complexing aliphatic carboxylic acid or water-soluble salt thereof.
A further object is to provide new methods useful in the control of dental calculus.
A still further object is to provide new compositions useful in reducing the accumulation of dental calculus on oral hard tissues.
The objects, advantages, and features of the subject invention will hereinafter appear from the following detailed description of the invention, including exemplary embodiments thereof.